BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BKS UNI

    MDR report key: 15165543 · Received August 4, 2022

    Report

    Report Number
    1722511-2022-00008
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    July 20, 2022
    Report Date
    July 20, 2022
    Manufacturer
    ORTHO DEVELOPMENT
    Product Code
    HSX
    UDI-DI
    00822409109319
    PMA / PMN Number
    K211471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A PATIENT WHO HAD UNICOMPARTMENTAL KNEE ARTHROPLASTY ON (B)(6) 2022 HAD AN ASTHMA ATTACK TWO WEEKS LATER AND SUBSEQUENTLY COMPLAINED OF KNEE PAIN. AN NEW X-RAY SHOWED TIBIAL FRACTURES THAT WERE NOT PRESENT AT INTRA-OPERATIVE AND POST OPERATIVE CHECKS. A SECOND SURGERY WAS PERFORMED ON (B)(6) 2022 TO PUT IN AN ORIF PLATE WITH BONE GRAFT LEAVING THE UNICOMPARTMENTAL KNEE COMPONENTS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166953 BKS UNI TOTAL KNEE ARTHROPLASTY PROSTHESIS HSX ORTHO DEVELOPMENT 762-2100 A263870 00822409109319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown